Standards Documents

List of ISBT 128 Standards Documents - PDF [Last Modified: 15 April 2015]

 

Technical Specification

This document is a comprehensive description of the rules surrounding the use of ISBT 128 as well as guidance in the interpretation of these rules. 

ST-001 ISBT 128 Standard Technical Specification Version 5.2.0 – PDF (1 MB)

The purpose of this document is to provide standards and guidance for the coding and labeling of medical products of human origin (MPHO): blood, cellular therapy products, tissues, milk, and organs, as well as those plasma derivatives for which ABO is relevant.

 

Standard Terminology

The Standard Terminology document provides definitions to all ISBT 128 terminology. The document should be used in conjunction with the ISBT 128 Product Description Code Database.

The version number of the Standard Terminology document will coincide with the first two numbers of the version of the applicable ISBT 128 Product Description Code Database. For example, Version 6.1 of the Standard Terminology shall coincide with Version 6.1.x of the ISBT 128 Product Description Code Database. 

Version 6.4: ST-002 Standard Terminology for Blood, Cellular Therapy, and Tissue Product Descriptions – PDF (2 MB)

Standard Terminology Version Control Sheet 2015 – PDF 

Standard Terminology Version Control Sheet 2014 – PDF
Standard Terminology Version Control Sheet 2013 – PDF
Standard Terminology Version Control Sheet 2012 – PDF   
Standard Terminology Version Control Sheet 2011 – PDF
Standard Terminology Version Control Sheet (Prior to 2011) – PDF

 

Standard Labeling - Human Tissues

ST-003 ISBT 128 Standard Labeling of Human Tissues v1.0.0 - PDF

This document is intended to help facilities and software developers design appropriate ISBT 128 labels for tissue products. Greater detail is given for labeling than that provided in the ISBT 128 Technical Specification.

 

Standard Labeling - Cellular Therapy Products

ST-004 ISBT 128 Standard Labeling of Cellular Therapy Products v1.1.0 - PDF

This document is intended to help facilities, label vendors, and software developers design appropriate ISBT 128 labels for cellular therapy products. Greater detail is given for labeling than that provided in the ISBT 128 Technical Specification.

 

Standard Labeling - Blood Components

ST-005 ISBT 128 Standard Labeling of Blood Components v1.0.0 - PDF

This document is intended to help facilities, label vendors, and software developers design appropriate ISBT 128 labels for blood products. Greater detail is given for labeling than that provided in the ISBT 128 Technical Specification.

 

Standard Labeling - Ocular Tissue

ST-009 ISBT 128 Standard Labeling of Ocular Tissue v1.0.0 - PDF

This document is intended to help facilities and software developers design appropriate ISBT 128 labels for ocular tissue products. Greater detail is given for labeling than that provided in the ISBT 128 Technical Specification.

 

Product Description Code Database

ST-010 ISBT 128 Standard Product Description Code Database v6.0.0 - PDF

The purpose of this document is to provide specifications and guidance for the use of the ISBT 128 Product Description Code Database.

 

Standard Coding and Labeling - Medical Devices

ST-011 ISBT 128 Standard Coding and Labeling of Medical Devices Using ISBT 128 v1.3.0 - PDF

The purpose of this document is to provide requirements and guidance for the labeling of medical devices containing a human tissue or cellular component using the ISBT 128 Standard.